A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.

Digestive System Disease Clinical Trial

Official title:

A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06283732
• Other study ID #: 20392
• Status: Completed
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: March 2024
• Source: Amway Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female.
• Aged 18-65 years.
• Willing to comply with study requirements.
• No known allergies to the ingredients listed in the product.
• Self-reported mild digestive issues (e.g., occasional bloating, stomach discomfort, occasional constipation, or occasional diarrhea).
• Generally healthy - do not live with any uncontrolled chronic disease .

Exclusion Criteria:

• Pre-existing chronic conditions that would prevent adherence to the protocol, including oncological and psychiatric disorders.
• Known severe allergic reactions that require an Epi-Pen.
• Women who are pregnant, breastfeeding, or attempting to conceive.
• History of severe diagnosed digestive disorders (e.g., IBS, IBD, Crohn's disease) or gastrointestinal-tract surgeries.
• Unwillingness to follow the study protocol.
• Invasive medical procedure within the last three weeks or planning one during the study period.
• History of substance abuse.
• Current participation or planning to participate in another research study.
• Regular consumption of probiotics, fiber, or prebiotic supplements within 3 weeks of the study.
• Regular intake of medications that may interfere with the study or study product (e.g., anticoagulants, laxatives, sedatives, beta-blockers, anti-acids) .

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Dietary Supplement:
• Greens powder
Participants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Amway Corp	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digestive Health Improvement	Measure the change in digestive health using daily diaries and the Bristol Stool Scale (BSS).	14 days from the start of intervention
Secondary	Quality of Life and Well-being Enhancement	Assess improvements in participants' quality of life, energy levels, satiety, and overall well-being through validated questionnaires.	14 days from the start of intervention